- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Genscript USA Inc. (Piscataway, NJ)
- …for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency drills. Serve ... risks. Ensure compliance with OSHA, EPA, and other applicable regulatory agencies. Conduct risk assessments, hazard analyses (eg, JHA,...as a liaison with regulatory bodies and external contractors/vendors. Drive continuous improvement in… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting , publication, and presentation at national and ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and AI toolsWorks closely with the site to gather data and reporting requirements and aligns tools/models/reportingWorks in collaboration with Validation function to ... in driving consistent statistical approaches and defending them to regulatory authorities is desirableExperience in collaborating with internal technical SMEs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …path forward for manufacturing issues.Real time review of all documentation, and reporting , in support of process unit operations, in accordance with Good ... will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. ... resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of a rapidly expanding, commercialized CAR-T product portfolio. This position will be reporting to Head of Global Sourcing and will develop and execute a long-term ... with Quality, Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for… more
- Tris Pharma (Monmouth Junction, NJ)
- …monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting , as applicableResearches and corrects accounting issues ... support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing ... Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget ... risk management to teams.Experience with Healthy Authority requirements and regulatory submission activities preferred.#DD1#OnsiteThe anticipated base pay range is:$107,482—$141,070… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget ... project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent knowledge… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication.Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Merck & Co. (Rahway, NJ)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identify and leverage synergies across analytics teams.Responsibilities- Data-Driven Insights Reporting and trend analytics: Lead the development and implementation ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a...required- 4 or More Years Experience with dashboarding and reporting tools like Tableau, Power BI and Looker required-… more
- SMBC (New York, NY)
- …support across the Advisory Function with respect to broker-dealer-applicable regulatory engagements, support function coordination, governance and reporting . ... Change Management + Compliance Alerts and other Communications Governance and Reporting : The Regulatory Governance Team is responsible for producing management… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an Assistant Controller.The Assistant Controller - reporting directly to, and collaborating closely with, the Controller - is a ... has direct ownership of technical accounting matters, revenue recognition, and financial reporting , and plays a central role in preparing for and managing financial… more
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck & Co. (Rahway, NJ)
- …own the roadmap and governance for Finance, Digital Payments, and SAP reporting /analytics platforms (BW/HANA), and will partner closely with Finance, IT, Operations ... considerations) within SAP and connected ecosystems.Oversee SAP BW and HANA reporting /analytics strategy, ensuring robust data models, timely financial reporting… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
